Satisfaite delivers optimised dose of vaginal lubricant and moisturiser to reduce the discomfort and improve the health of the vaginal mucosa
Image: US Food and Drug Administration Office in Queens, New York City, US. Photo: Courtesy of CaptJayRuffins/Wikipedia.
FemmePharma, a company dedicated to women’s menopausal health, has received the US Food & Drug Administration (FDA) 510(k) approval to manufacture and commercialise its Satisfaite delivery system.
The Satisfaite delivery system is an intravaginal personal lubricant, designed to moisturise and lubricate the vagina to relieve the symptoms of menopause.
FemmePharma president and CEO Gerianne DiPiano said: “We are excited that at FemmePharma was able to meet the exacting standards set by the US FDA, and we are committed to delivering products that are differentiated, not only by adherence to exacting standards but also geared to providing a product that meets the needs of women and that they feel they can use with confidence.”
Satisfaite met the safety and effectiveness standards for a Class 2 medical device
FemmePharma said that the physical and chemical properties of its delivery system offer an aesthetically sophisticated and easy to use alternative to existing lubricants and moisturizers.
In addition, the regulatory approval underlines that Satisfaite is in line with the safety and effectiveness standards for a Class 2 medical device. Satisfaite will be commercially sold in first quarter of 2020.
According to the company, approximately half of the women going through menopause are suffering vulvar and vaginal symptoms including vaginal dryness, burning, urinary urgency, frequency, irritation and pain during intercourse, due to reduced oestrogen levels in the body.
If the condition is left untreated, the menopause symptoms may negatively impact the overall health, emotional well-being and quality of life for women.
Satisfaite delivers an optimised dose of vaginal lubricant and moisturizer
Satisfaite delivers an optimised dose of the company’s pharmaceutical-grade vaginal lubricant and moisturizer to reduce the discomfort and improve the health of the vaginal mucosa.
FemmePharma said that its Satisfaite can be used alone or in combination with complementary vulvar moisturizers, including Satisfem Gel and Satisfem Bud, as a daily self-care regimen.
Satisfem Gel is made without using hormones and has a hydrating formula to reduce vulvar itching, burning and irritation. Satisfem Bud is comprised of a hydrating formula, in a single-use swab applicator.